NCT02373631

Brief Summary

The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

February 10, 2015

Last Update Submit

May 22, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Knee Pain Intensity (NPRS)

    Baseline, 2 Weeks, 6 Weeks, 3 Months

  • Change in Knee Osteoarthritis Index (Pain)

    5 Questions each worth 0-4 points with a maximum score of 20 points possible

    Baseline, 2 Weeks, 6 Weeks, 3 Months

  • Change in Knee Osteoarthritis Index (Stiffness)

    2 Questions each worth 0-4 points with a maximum score of 8 points possible

    Baseline, 2 Weeks, 6 Weeks, 3 Months

  • Change in Knee Osteoarthritis Index (Physical Function)

    17 Questions each worth 0-4 points with a maximum score of 68 points possible

    Baseline, 2 Weeks, 6 Weeks, 3 Months

  • Change in Knee Osteoarthritis Index (Total)

    24 Questions each worth 0-4 points with a maximum score of 96 points possible

    Baseline, 2 Weeks, 6 Weeks, 3 Months

Secondary Outcomes (2)

  • Change in Global Rating of Change Score (GROC)

    2 Weeks, 6 Weeks, 3 Months

  • Change in Medicine Intake (Frequency of medication intake)

    Baseline, 3 months

Study Arms (2)

Dry Needling, Conventional PT

EXPERIMENTAL
Other: Dry Needling, Conventional PT

Conventional PT

ACTIVE COMPARATOR
Other: Conventional PT

Interventions

Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)

Dry Needling, Conventional PT

Conventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total)

Conventional PT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
  • Report of at least 3 of the following per Altman et al. (1986)
  • Over 50 Years of age
  • Less than 30 minutes of morning stiffness
  • Crepitus on active motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth of synovium

You may not qualify if:

  • Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
  • History of previous surgery to the knee
  • History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
  • History of a surgical procedure on either lower extremity in last 6 months
  • Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
  • Weakness involving a major muscle group of the lower extremity.
  • Diminished patella or achilles tendon reflex
  • Diminished or absent sensation to pinprick in lower extremity dermatome
  • Involvement in litigation or worker's compensation regarding knee pain.
  • Any condition that might contraindicate the use of electro-needling
  • The patient is pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

Location

Related Publications (1)

  • Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • James Dunning, DPT FAAOMPT

    American Academy of Manipulative Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DPT MSc FAAOMPT

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations